The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Device Description

The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures.

The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following:

5x - ClearPoint Bone Screw Fiducials
1x Bone Screw Fiducial holder
1x Screwdriver

The Bone Screw Fiducial is made of titanium and comprised of a threaded portion that is screwed into a patient's skull and a non-threaded, exposed length that protrudes from the patient's head. The head contains a feature for compatibility with a T8 Torx screwdriver and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool.

The Bone Screw Holder is intended to assist in holding the Bone Screw Fiducials securely to the screwdriver during anchoring. This is accomplished by allowing the screwdriver to mate with the Bone Screw Fiducial without the Bone Screw Fiducial separating from the assembly therefore allowing it to be anchored to the skull.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ClearPoint Bone Screw Fiducials. It does not contain information related to software or AI/ML. The document describes a medical device, specifically bone screw fiducials, and compares them to a predicate device. The testing described is "bench testing" focusing on physical, performance, and safety requirements, and simulated workflow testing.

Therefore, for aspects related to AI/ML or a multi-reader multi-case (MRMC) study, the answer will be that this document does not contain that information.

Here's an analysis based only on the provided text, addressing the points where information is available:

1. A table of acceptance criteria and the reported device performance

The document states: "The results from all testing demonstrated that the ClearPoint Bone Screw Fiducials comply with all design and performance specifications."
It also mentions: "ClearPoint Bone Screw Fiducials have been demonstrated to meet all test specifications and has been shown to be as safe, as effective, and to perform as well as the predicate device."

However, the specific "acceptance criteria" and "reported device performance" metrics (e.g., specific thresholds for physical properties, accuracy in imaging, etc.) are not detailed within this document. The document summarizes that the device met these criteria but does not provide them in a table format.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "bench testing" and "simulated workflow testing." It does not specify sample sizes for these tests or discuss data provenance (country of origin, retrospective/prospective) in the context of clinical data or patient-derived data, as the device is physical hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This N/A. Ground truth, in the context of AI/ML, refers to expert-labeled data. The testing described is bench testing of a physical device. There is no mention of experts establishing a "ground truth" for imagery or diagnostic performance here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This N/A. No adjudication method is described, as the testing is for physical device performance, not interpretation of data by multiple readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was conducted or mentioned in this document. This document is for a physical medical device (bone screw fiducials), not a software or AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done or mentioned. This document is for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This N/A. For a physical device, "ground truth" typically refers to engineering specifications met through measurements and physical verification. The document states "Design Verification testing was performed relative to these specifications." These specifications serve as the "ground truth" for the device's physical and performance characteristics. There is no biological or diagnostic ground truth described in this submission.

8. The sample size for the training set

This N/A. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established

This N/A. There is no training set mentioned, as this is not an AI/ML device.

Summary regarding AI/ML aspects:

The provided document describes a 510(k) premarket notification for a physical medical device (ClearPoint Bone Screw Fiducials). It relies on bench testing to demonstrate performance and substantial equivalence to a predicate device. The information requested regarding AI/ML-specific testing, such as MRMC studies, training/test set sizes, data provenance, expert ground truth establishment, and algorithm-only performance, is not relevant to this submission and therefore not present in the provided text.

Summary

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January 12, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ClearPoint Neuro, Inc. Brennan Sullivan Regulatory Affairs Manager 120 S. Sierra Avenue, Suite 100 Solana Beach, California 92075

Re: K233144

Trade/Device Name: ClearPoint Bone Screw Fiducials Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 8, 2023 Received: December 11, 2023

Dear Brennan Sullivan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the text "Adam D. Pierce -S" in a large, clear font. The text is arranged vertically, with "Adam D." on the top line and "Pierce -S" on the bottom line. The text appears to be part of a larger document or image, as there is additional text to the right that is partially visible.

Digitally signed by Adam D. Pierce -S Date: 2024.01.12 16:44:57 -05'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233144

Device Name ClearPoint Bone Screw Fiducials

Indications for Use (Describe)

The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

510(k) Summary for the ClearPoint Neuro ClearPoint Bone Screw Fiducials (per 21CFR 807.87)

1. SUBMITTER/510(K) HOLDER

ClearPoint Neuro, Inc. 120 S. Sierra Ave. Suite 100 Solana Beach, CA 29075 Contact Person: Brennan Sullivan Telephone: 617-678-1028

Date Prepared: January 11, 2024

2. DEVICE INFORMATION

Name of Device:	ClearPoint Bone Screw Fiducials
Common or Usual Name:	Bone Screw Fiducials
Classification:	Neurological Stereotaxic Instrument, 21CFR 882.4560
Regulatory Class:	Class II
Product Code	HAW

3. PREDICATE DEVICE

Medtronic Unibody Bone Fiducials K033619

4. DEVICE DESCRIPTION

The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures.

The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following:

5x - ClearPoint Bone Screw Fiducials
1x Bone Screw Fiducial holder ●
1x Screwdriver ●

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and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool.

న. INDICATIONS FOR USE

The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The ClearPoint Bone Screw Fiducials are substantially equivalent to the predicate device MedTronic UniBody Bone Fiducials, subject of K033619. They are identical in indications for use and both the proposed ClearPoint Bone Screw Fiducials and the predicate are bone screw fiducials made out of titanium. The devices are both comprised of a threaded portion that is screwed into a patient's skull and non-threaded, exposed length that protrudes from the patient's head and is topped by a rounded, spherical head. The top of the head of both devices is equipped with a feature for compatibility with a screwdriver.

Both the subject device and the predicate are placed orthogonally into the patient's skull prior to CT-imaging to serve as fixed reference points for registration. They are both visible under CT and a minimum of 4 of each are required for proper registration.

The difference between the ClearPoint Bone Screw Fiducials and the Unibody Bone Fiducials are minor design differences to the dimensions and the screwdriver compatibility. These differences do no introduce any risks of safety or efficacy. Table 12-1 provides a side-by-side comparison of the ClearPoint Bone Screw Fiducials to the Unibody Bone Fiducials.

	ClearPoint Bone Screw Fiducials	Medtronic Unibody Bone Fiducials(Navigus Unibody Fiducial MarkerSystem)K033619	Comparison
Classification	21 CFR 882.4560	21CFR 882.4560	Identical
Product Code	HAW	HAW	Identical
DeviceDescription	The ClearPoint Bone ScrewFiducials are titanium bone screwfiducials that are anchored directly tothe patient's head and are used as afixed reference point to register apre-operative image to the opticalnavigation system	The Medtronic Unibody BoneFiducials are titanium bone screwfiducials anchored directly to apatient's head and are used as fixedreference points for presurgery CTimaging for patients requiringstereotactic surgery.	Identical
Indications forUse	The ClearPoint Bone ScrewFiducials are intended to providefixed reference point(s) in patients	The Navigus Unibody Fiducial MarkerSystem is intended to provide fixedreference point(s) in patients requiring	Identical

Table 5-1: Side-by-side comparison of ClearPoint Bone Screw Fiducials with Predicate

	ClearPoint Bone Screw Fiducials	Medtronic Unibody Bone Fiducials(Navigus Unibody Fiducial MarkerSystem)K033619	Comparison
	requiring stereotactic surgery inconjunction with CT imaging.	stereotactic surgery in conjunctionwith CT imaging.
Principle ofOperation	A minimum of five locations forplacement of the bone fiducialsshould be chosen. The locationsshould cover the entire craniumand be noncoplanar. Bone fiducials are inserted intothe bone screw holder. The bonescrew holder is positioned andheld to ensure the bone fiducialis placed orthogonally to theskull surface. Using a manual or poweredscrewdriver the ClearPointBone Screw Fiducial is drivenuntil it is flush with the skull. This is repeated for theremaining bone fiducials. A manual screwdriver is used toensure each bone fiducial isfully seated. CT imaging can then beperformed to acquire thepatient's CT scans	A minimum of four locations forplacement of the bone fiducialsshould be chosen. The locationsshould cover the entire craniumand be noncoplanar. Bone fiducials are inserted througha screwdriver guide sleeve. Theguide sleeve is positioned and heldto ensure the bone fiducial is placedorthogonally to the skull surface. Using a powered screwdriver withthe bone fiducial is driven until it isflush with the skull. This is repeated for the remainingbone fiducials. A manual screwdriver used toensure each bone fiducial isfully seated. A protective cap is inserted overeach bone fiducial. CT imaging can then beperformed to acquire thepatient's CT scans.	Similar
Length	17 mm	7 mm10 mm13 mm	Different
Screw Head	Torx	1.6-mm cross-type blade t	Different
Materials	Bone Fiducials - TitaniumBone Screw Fiducial Holder -PolycarbonateScrewdriver - Titanium, ABS &Nylon	Bone Fiducials – TitaniumProtective Caps – Thermo-plasticScrewdriver Guide - Polycarbonate	Similar
Biocompatibility	Yes	Yes	Identical
Sterile	Yes	Yes	Identical
Single Use	Yes	Yes	Identical

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7. BENCH TESTING

ClearPoint Neuro has performed extensive verification testing to demonstrate that the ClearPoint Bone Screw Fiducials are as safe and effective for its intended use as the predicate device. The development of the subject device was conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification testing was performed relative to these specifications. These tests included verification of physical, performance, and safety requirements, as well as simulated workflow testing for usability and effectiveness. The

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results from all testing demonstrated that the ClearPoint Bone Screw Fiducials comply with all design and performance specifications.

Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the ClearPoint Bone Screw Fiducials function as intended and are substantially equivalent to the legally marketed Medtronic Unibody Bone Fiducials.

8. CONCLUSION

The subject ClearPoint Bone Screw Fiducials and the predicate Unibody Bone Fiducials have identical indications for use and similar technological characteristics and principles of operation. ClearPoint Neuro has performed extensive bench testing to demonstrate that the differences between ClearPoint Bone Screw Fiducials and the predicate device do not raise any risks of safety or efficacy. ClearPoint Bone Screw Fiducials have been demonstrated to meet all test specifications and has been shown to be as safe, as effective, and to perform as well as the predicate device.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).